MAUDE Adverse Event Report: Medline Industries, LP NAMIC; DBD-MTS,LEFT HEART,KIT,-,WHITE

Catalog Number	000000000060183137
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "transducer cracked during setup of procedure.".
Additional Manufacturer Narrative
The reported issue was the transducer cracked during the setup of procedure.A review of the device history records was performed for the indicated packaging and component lots, and the sample was reviewed.Based on the sample supplied from the customer, the customer's complaint of "bond break between transducer and one way stopcock" is deemed confirmed; possible root causes may be due to the end user trying to tighten the bonded connection or handling damage during transit.There does not appear to be any manufacturing defects related to the returned bonded assembly, and no corrective action is needed at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: NAMIC
• Common Device Name: DBD-MTS,LEFT HEART,KIT,-,WHITE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50917408
• Report Number: 1417592-2026-52318
• Device Sequence Number: 5778135
• Product Code: OEZ
• UDI-Device Identifier: 20193489049937
• UDI-Public: 20193489049937
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 000000000060183137
• Device Lot Number: 23GBD300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown